Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K936114Substantially Equivalent

Birtcher Pericardial Knives

Birtcher Medical Systems, Inc., Irvine CA / Traditional, Substantially Equivalent

K936114 is the FDA 510(k) clearance record for BIRTCHER PERICARDIAL KNIVES, a class II device, cleared for Birtcher Medical Systems, Inc. on under FDA product code GCJ (Laparoscope, General & Plastic Surgery). FDA's definition for product code GCJ reads: "Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available...". FDA records list 13 510(k) clearances for Birtcher Medical Systems, Inc., from to . As of , FDA records show no recalls naming K936114.

Clearance record

Decision date
Received
(439 days to decision)
Product code
GCJ Laparoscope, General & Plastic Surgery
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Birtcher Medical Systems, Inc. 50 Technology Dr., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code GCJ

Trailing 12 months
27 clearances under product code GCJ in the twelve months to October 2026, February 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code GCJ, trailing twelve months
MonthClearances
November 20252
December 20250
January 20263
February 20264
March 20260
April 20263
May 20264
June 20264
July 20263
August 20262
September 20262
October 20260